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Clinical Drug Development,MSBS 5120S

Course Director:   Dr. William J. Welsh

Dept. of Pharmacology

welshwj@rwjms.rutgers.edu

 

 

Overview

This course provides a detailed overview of the drug and biologics development process from discovery through regulatory approval and beyond to marketing strategy. Special attention is given to the roles, functions and significance of the various disciplines involved in the R&D process, their interactions with each other, and the strategic management of these functions. Attention will also be given to key technologies used throughout the R&D process, specifically: biomarker development, imaging, computer‐aided drug design and examples of their application. The economics of pharmaceutical R&D as well as trends in licensing, outsourcing and partnerships will be covered. The student will gain an understanding of R&D strategy and the relationship between R&D and overall organizational success.

 

Pedagogy

The course will employ lectures notes, assigned readings, case analyses and individual homework assignments. Each student will analyze three cases involving health care, translational medicine, and drug development, and corporate structure and culture of biopharmaceutical companies.  

 

Learning Goals

After taking this course, the student will be able to:

  • Understand the drug development process
  • Understand the scientific, financial and managerial challenges involved in drug development
  • Understand the importance of translational medicine in drug development
  • Understand the interaction of risk and strategy in drug development

 

Required Texts

  • Drugs‐From Discovery to Approval, Second Edition by Rick Ng. Wiley‐Blackwell 2009 ISBN 978‐0‐470‐19510‐9.
  • Code of Federal Regulations (CFR): www.gpoaccess.gov.

 

Class Notes

Class lectures will be given except for Week 5, Week 10, and Week 13. On these weeks, you will work on the three assigned Case Studies.

 

Required Readings

Required and supplemental readings are outlined in the course schedule.

 

Assignments

 

Homework Questions

Each week, there will be a series of homework questions, to aid in helping you test your understanding of the material. Students should come prepared to discuss their answers to each week’s questions.

 

Case Studies

The students will analyze three case studies in their 15‐week curriculum; Cases are set at a point in time and describe a real problem or situation faced by the subject organization. When evaluating a case read the case through once quickly to gain a general understanding of the situation; read it a second time, this time noting items such as:

  • The central problem or issue posed by the case.
  • What is known or unknown about the problem?
  • The opportunities and options available for addressing the problem.

 

Discuss the strategic nature of the case, the ramifications of different decisions that might have been made and how you would have handled the case. Be sure not to ignore the strategic, business and financial aspects of the case. Research what has happened since the case took place; was the strategy described in the case successful or not; and if not, why not? Describe what you learned from the case (lessons learned). Use standard methods of analysis that you may have learned in other classes or in your work, such as SWOT, decision‐tree, etc.

 

Case analyses should be 3 – 5 pages in length and should NOT be a recapitulation of the events or the case, but should be an analysis of the case. These should be in Microsoft Word format (or some compatible format).

 

Basis for Grade Assignments

 

MBS: Pre Clinical Pharmacology

Homework                                              33%

Case Studies                                            67%

 

Grades will be  

 

A, B+, B, C+, C and F

 

Course Schedule

 

Week 1 Introduction to Pharmaceutical Research & Development

Required Reading: Ng ‐ Chapter 1; Littman & Krishna ‐ Chapter 1

 

Week 2 Drug Discovery

Required Reading: Ng ‐ Chapters 2‐4

 

Week 3 Preclinical Development

Required Reading:  Ng ‐ Chapter 5

 

Week 4: Modeling and Simulation in Drug Discovery

Required Reading: Handout

 

Week 5: Case Study 1: Eli Lilly ‐ Developing Cymbalta

Required Reading: Handout

 

Week 6 Regulatory Affairs Required Reading:

Ng ‐ Chapters 7 and 8

 

21 CFR 58, subparts 15, 29, 35, 43, 47, 49, 63, 81, 90, 105, 120, 130

21 CFR Part 50

21 CFR Part 312, subparts 3, 6, 7, 20, 21, 22, 23, 32, 33, 40

 

Week 7: Clinical Trials and Drug Safety

Required Reading: Ng ‐ Chapter 6

 

Week 8: R&D Organizations & Strategy

Required Reading: Ng – Chapter 8‐10

 

Week 9: Biopharmaceuticals  

Required Reading: Ng – Chapter 7

 

Week 10: Case Study 2: Pfizer Inc.‐Building an Innovation Center  

Required Reading: Handout

 

Week 11: Pharmaceutical Industry in the 21st Century

Required Reading: Ng ‐ Chapter 14‐15

 

Week 12: Pharmaceutical Formulation & Good Manufacturing Practices (GMP)

Required Reading: Ng – Chapter 16

 

Week 13: Case Study 3: Sirtris Pharmaceuticals ‐ Living Healthier, Longer

Required Reading: Handout